DIN EN ISO 13485

The unlimited certification for medical devices is of vital importance to us; it allows us to act as a manufacturer (“organization”) in accordance with the Medizinproduktegesetz (MPG) and deliver end products and components to distribution partners and OEM customers.

CE-label

For our medical products, we issue the certificate of complicance with EU directive 93/42/EWG (medical devices) and 98/79/EWG (in vitro diagnostics).

Intellectual Property

As a side product of intense development efforts, innovations are continuously generated and protected by roughly 30 patents and utility patents.

FDA-approval

We are inspected on a regular basis by the FDA, always with positive outcome. Our blood mixing scale is approved for sale and usage in the US market.

Certificate: DIN EN ISO 13485